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Field Notes: When The Test Report Is The Counterfeit
1.
Aug 10
•
Monica Burt
1
The Quality Signal: Where MedTech Compliance Meets Competitive Strategy
Human error is not a root cause
Aug 7
•
Monica Burt
July 2026
Field Notes: Your Supplier's Recall Is Your Recall
1.
Jul 27
•
Monica Burt
1
Field Notes: Seven Symptoms, One Disease
Week of July 13, 2026.
Jul 20
•
Monica Burt
1
June 2026
Field Notes: The Center of Gravity Moved
Risk management took the top spot, PCCP became architecture, and the OAI came back. Three signals the post-QMSR posture is firmer than the quiet…
Jun 29
•
Monica Burt
1
Field Notes: HF Final, Destruction Gap, Vendor Squeeze
A finalized guidance with a records trap, two recalls that ask the same question, and a QMS vendor that just doubled its price.
Jun 23
•
Monica Burt
2
Field Notes: The Clock Runs Both Ways
Three regulatory and industry shifts that signal where medtech enforcement and operations are heading next.
Jun 3
•
Monica Burt
2
May 2026
Field Notes: First QMSR Cycle, First Cracks
What the first months of QMSR enforcement are already revealing about FDA calibration, inspection behavior, and regulatory drift.
May 21
•
Monica Burt
1
The Signal: FDA Did Not Go Soft. FDA Reloaded.
One hundred days into QMSR, the headline number looks like relief.
May 20
•
Monica Burt
1
Field Notes: The Stage and the Press Release
FDA’s AI strategy is evolving faster than its guidance — and the gap is becoming impossible to ignore.
May 12
•
Monica Burt
1
FDA's AI Will See You Now
FDA built the AI inspector faster than the AI rulebook — and MedTech is already feeling the impact
May 8
•
Monica Burt
2
Field Notes: Sharper, Not Softer
AI oversight, disappearing records protections, and the new inspection reality under QMSR.
May 8
•
Monica Burt
1
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